An interventional study of Video capsule investigation in Lynch Syndrome, Li Fraumeni Syndrome and PTEN Hamartoma Syndrome, sponsored by Royal Marsden NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Royal Marsden NHS Foundation Trust · Not applicable, Interventional, and Diagnostic
Among 12 studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United Kingdom — 8 open to participants now, 9 under way, none of them phase 3. Colorectal Neoplasms, Hereditary Nonpolyposis · United Kingdom.
Among the 12 studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United Kingdom, this one is one of 3 that started in 2024, is one of 4 with no phase, and was the 8th registered.
145 studies on the registry are indexed under Colorectal Neoplasms, Hereditary Nonpolyposis; 59 are open to participants now.
Browse Colorectal Neoplasms, Hereditary Nonpolyposis studies →8 of the 12 studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United Kingdom are open now. Recruiting first, the newest first:
Vividion Therapeutics, Inc. · Sites in United Kingdom, United States, Argentina and 19 more countries
Ages 18+
Queen Mary University of London · Sites in United Kingdom
Ages 18+ · Women only · Healthy volunteers
London North West Healthcare NHS Trust · Sites in United Kingdom
Ages 18–99 · Healthy volunteers
Royal Marsden NHS Foundation Trust · Sites in United Kingdom
Ages 18+
Institute of Cancer Research, United Kingdom · Sites in United Kingdom
Ages 18+ · Men only
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 43 Colorectal Neoplasms, Hereditary Nonpolyposis studies recruiting now, 32 (74%) set no upper age limit and 4 (9%) stop at 75 or younger; 4 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2024.
This study's planned enrollment of 25 is below the median of 200 across 75 interventional studies indexed under Colorectal Neoplasms, Hereditary Nonpolyposis.
Median enrollment 370 across the 6 interventional studies, 841 across the 6 observational. Of the 3 that completed or were terminated, 1 (33%) have results posted.
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1 of 12 have an industry lead sponsor. The 9 most frequent:
Royal Marsden NHS Foundation Trust is the lead sponsor of 274 studies on the registry; 53 are open to participants now.
Royal Marsden NHS Foundation Trust has 2 studies filed under Colorectal Neoplasms, Hereditary Nonpolyposis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Surveillance for colorectal cancer (CRC) in patients predisposed to develop CRC during their lifetime has been impacted by access to colonoscopy suites and endoscopy specialists in the past couple of years. An alternative method, namely the colon capsule, has been proposed, however this investigation is time consuming for the clinician and the images require up to one hour (30-60 minutes) reading to issue a result. The investigators propose to obtain images from paired colonoscopies and colon capsules with the purpose of developing an AI algorithm which could aid the clinicians in reading the colon and expand access to this investigation.
The main aim of the study is to determine whether it is possible to obtain usable paired images from patients with Lynch and other cancer predisposition syndromes. This will depend on the willingness of the patients to take part in the study and the technical ability of obtaining data from paired images of colonoscopies and colon capsule.
At recruitment, participants will undergo a colon capsule investigation, followed by a routine colonoscopy as per their normal standard of care. Paired endoscopic images from colonoscopies and colon capsules will be collected and anonymised data will be accessed by the bioinformatician for analysis.
If the study will be successful in reaching the primary endpoint, further trials will be opened, allowing for a larger population to be included and to obtain more robust data, which eventually can lead to validated AI algorithms and application of computer-aided video-capsules examination as a screening tool in at-risk population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: Video capsule investigation
Participants will undergo both a video capsule examination and a colonoscopy on the same day.
Also known as: Colonoscopy
The proportion of paired images the bioinformatician assesses as useful for the development of algorithm
Time frame: 18 months
The proportion of patients at high-risk as defined by inclusion criteria who agree to undergo video capsule examination.
Time frame: 18 months
The proportion of patients who undergo both video capsule examination and colonoscopy, from whom it is possible to obtain paired images
Time frame: 18 months
The description of any adverse events collected for the Pillcam procedure.
All adverse events will be collected using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: 18 months
Started Mar 2024 (actual). Primary completion is estimated for Oct 2025, 19 months after the start.
Of 37 interventional studies with no phase under Colorectal Neoplasms, Hereditary Nonpolyposis, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 86. This study's planned 19 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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